108,000 people of more than 140 nationalities work at Novartis around the world. NBS CONEXTS is an internal service organization and provides clinical project management services to a variety of Novartis customers. These may range from CPM working within a customer team to CPM leading a study that has been fully outsourced to NBS CONEXTS.
Responsible for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations, IITs, Digital Solutions etc.) executed by CONEXTS on behalf of Novartis Organizations, under the lead of Senior Clinical Project Manager (Sr. CPM) (where applicable). Work with the Sr. CPM (where applicable), Clinical Operations Specialist (COS) and Team leading the planning and implementation of all operational aspects of assigned clinical studies from concept to reporting/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures).
Responsible for ongoing and effective collaboration with colleague/customer, other Line Functions and third-party vendors. Track performance and quality aspect.
CONEXTS is an internal service organization and provides clinical services to a variety of Novartis colleague/customers. These may range from CPM working within a col-league/customer team to CPM leading a study that has been fully outsourced to CONEXTS. Depending on the service provided by CONEXTS, the CPM may be responsible for all or part of the below listed activities or other responsibilities as deemed appropriate or activities to support business continuity.
Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved or support the Sr. CPM (where applicable).
Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures. Might be required to support or lead other projects/program, in collaboration with cross-functional teams.
Responsible for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard with local regulation requirement.
As applicable, support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required. Also, if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.
As applicable, responsible for review of all site visit related reports and quality control of monitoring activities in timely manner.
In collaboration with the CONEXTS or colleague/customer data review team (Central data Monitors, Data Managers, Statisticians, and third parties), contribute to the study data ongoing medical/scientific quality review to ensure high quality data are transferred/available in a timely manner.
Coordinate the data analysis and interpretation for first interpretable results (where applicable) with the CONEXTS or colleague/customer Medical Representative.
Work with Sr. CPM (where applicable) in contributing to the development of Clinical Study Protocol, MAP treatment plan, amendments, Informed Consent Forms and other study essential documents, and contributing to clinical sections of regulatory documents (Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, re-view of clinical trial application packages) as required; obtain approval from col-league/customer. Responsible for Clinical Study Report, either directly contributing to or managing the report writing, or by liaising with the CONEXTS or colleague/customer medical writing/narrative group to ensure report is completed according to current requirements.
In partnership with Clinical Operations Specialists (COS) (where applicable) responsible for the set up and maintenance of the Trial Master File (TMF), Clinical Trial Management System (CTMS) and other required systems as appropriate.
Work with CTT and QA to identify potential issues and implement actions to resolve them. Where applicable oversee the work of assigned Clinical Operations Specialists(s), ensuring clear delegation /assignment of duties are documented
Work with Sr. CPM (where applicable) and COS for the development, management and tracking of study budget (internal and external costs) working closely with the CONEXTS Finance and colleague/customer representative. Responsible for accuracy of study information in all study databases and tracking systems. Responsible for (or support the Sr. CPM where applicable) the preparation and presentation of the study budget to colleague/customer representatives. Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab).
Execute clinical services and meet planned deliverables, in line with defined roles and responsibilities agreed with customers
Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives. Act as a mentor, including support the training and onboarding of new associates. Developing a continuous process of learning and reflection and solution-orientated approach. Champion the implementation of operational changes and transitions as required.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Relevant educational background in life sciences/Healthcare (Ideally a Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience
Approximately 8 years’ of Global Clinical Operations experience with managerial experience in designing, planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization.
Proven ability to work independently in a complex matrix environment (including remote), including leading cross-functional team.
Solid project management skills.
Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills.
Strong customer-oriented mindset.
Ability to resolve issues with minimal supervision and understand when to escalate.
Willingness to act accountably in project/study management.
Travel internationally/domestically as required.
Fluent English (oral and written).
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 12,500 CZK per year; Meal vouchers in amount of 90 CZK for each working day (full tax covered by company); Car Allowance; MultiSport Card. Find out more about Novartis Business Services: https://www.novartis.cz/
Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Research & Development